A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo

Last updated: March 21, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Scalp Disorders

Rash

Dermatitis, Atopic

Treatment

Amlitelimab

PPS vaccine

Tdap vaccine

Clinical Study ID

NCT06015308
SFY17915
U1111-1280-8357
SFY17915
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis (AD).

The purpose of this study is to compare the immune responses to concomitantly administered Boostrix (tetanus, diphtheria, and acellular pertussis [Tdap]) and Pneumovax 23 (PPSV) vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus placebo. The study will evaluate the percentage of participants achieving a positive anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response at Week 16 (key secondary endpoint).

Study details include:

The study duration will be up to 36 weeks (for participants not entering the LTS17367 [RIVER-AD]).

The screening period will be 9 days to 4 weeks. The treatment duration will be up to 16 weeks. The post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7 (or 6 for those entering LTS17367 [RIVER-AD]).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be 18 years of age (when signing informed consent form)

  • Diagnosis of AD for at least 1 year (defined by the American Academy of DermatologyConsensus Criteria)

  • Documented history (within 6 months before screening) of either inadequate responseor inadvisability to topical treatments

  • Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3or 4 at baseline visit

  • Eczema area and severity index (EASI) score of 12 or higher at baseline

  • AD involvement of 10% or more of body surface area (BSA) at baseline

  • Able and willing to comply with requested study visits and procedures

  • Body weight ≥40 kg and ≤150 kg

Exclusion

Exclusion Criteria:

  • Skin co-morbidity that would adversely affect the ability to undertake ADassessments

  • Receipt of any vaccine (expect influenza and COVID-19 vaccines) within 3 monthsprior to screening

  • Receipt of any pneumococcal vaccine within approximate timeframe of 5 years prior toscreening

  • Prior receipt of two or more doses of Pneumovax 23 at any time

  • Receipt of any tetanus-, diphtheria-, or pertussis-containing vaccine withinapproximate timeframe of 5 years prior to screening

  • Participants for whom administration of the pneumococcal vaccine provided in thisstudy is contraindicated or medically inadvisable, according to local label of thevaccine

  • Participants for whom administration of the tetanus, diphtheria, and pertussisvaccine provided in this study is contraindicated or medically inadvisable,according to local label of the vaccine

  • Having received any of the specified therapy within the specified timeframe(s) priorto the baseline visit

  • Known history of or suspected significant current immunosuppression

  • Any malignancies or history of malignancies prior to baseline (excludingnon-melanoma skin cancer excised and cured >5 years prior to baseline)

  • History of solid organ or stem cell transplant

  • Any active or chronic infection including helminthic infection requiring systemictreatment within 2 weeks prior baseline

  • Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C atscreening visit

  • Participants with active tuberculosis (TB), latent TB, a history of incompletelytreated TB, suspected extrapulmonary TB infection, or who are at high risk ofcontracting TB

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Design

Total Participants: 215
Treatment Group(s): 4
Primary Treatment: Amlitelimab
Phase: 2
Study Start date:
October 06, 2023
Estimated Completion Date:
February 27, 2026

Study Description

The study duration will be up to 36 weeks

Connect with a study center

  • Investigational Site Number : 1240019

    Calgary, Alberta T2W 4X9
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240023

    Calgary, Alberta T3A 2N1
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240016

    Edmonton, Alberta T5J 3S9
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240014

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240020

    Hamilton, Ontario L8L 3C3
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240017

    London, Ontario N6H 5L5
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240018

    Newmarket, Ontario L3Y 5G8
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240042

    Niagara Falls, Ontario L2E 6A6
    Canada

    Site Not Available

  • Investigational Site Number : 1240024

    Richmond Hill, Ontario L4B 1A5
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240021

    Toronto, Ontario M2N 3A6
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240026

    Toronto, Ontario M4E 1R7
    Canada

    Active - Recruiting

  • Allervie Clinical Research Site Number : 8401101

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Clinical Research Center of Alabama - Homewood- Site Number : 8401101

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Center for Dermatology and Plastic Surgery Site Number : 8401119

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Center for Dermatology and Plastic Surgery- Site Number : 8401119

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Orange County Clinical Trials- Site Number : 8401271

    Anaheim, California 92801
    United States

    Active - Recruiting

  • Orange County Research Institute Site Number : 8401271

    Anaheim, California 92801
    United States

    Active - Recruiting

  • First OC Dermatology Site Number : 8401025

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • First OC Dermatology- Site Number : 8401025

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Center for Dermatology Clinical Research Site Number : 8401018

    Fremont, California 94538-1614
    United States

    Active - Recruiting

  • Center for Dermatology Clinical Research- Site Number : 8401018

    Fremont, California 94538
    United States

    Active - Recruiting

  • Valley Research Site Number : 8401097

    Fresno, California 93720
    United States

    Active - Recruiting

  • Valley Research- Site Number : 8401097

    Fresno, California 93720
    United States

    Active - Recruiting

  • Paradigm Clinical Research Centers- Site Number : 8401273

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Paradigm Clinical Research Site Number : 8401273

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Sunwise Clinical Research Site Number : 8401022

    Lafayette, California 94596
    United States

    Active - Recruiting

  • Sunwise Clinical Research- Site Number : 8401022

    Lafayette, California 94549
    United States

    Active - Recruiting

  • Antelope Valley Clinical Trials Site Number : 8401099

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Antelope Valley Clinical Trials- Site Number : 8401099

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Torrance Clinical Research Institute, Inc. Site Number : 8401027

    Lomita, California 90717
    United States

    Active - Recruiting

  • Torrance Clinical Research- Site Number : 8401027

    Lomita, California 90717
    United States

    Active - Recruiting

  • California Allergy and Asthma Site Number : 8401099

    Los Angeles, California 90025
    United States

    Site Not Available

  • Clinical Science Institute Site Number : 8401028

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Clinical Science Institute- Site Number : 8401028

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Velocity Clinical Research - Denver Site Number : 8401168

    Denver, Colorado 80209
    United States

    Active - Recruiting

  • Daxia Trials Site Number : 8401145

    Boca Raton, Florida 33431
    United States

    Active - Recruiting

  • Daxia Trials- Site Number : 8401145

    Boca Raton, Florida 33431
    United States

    Active - Recruiting

  • Encore Medical Research of Boynton Beach LLC. Site Number : 8401030

    Boynton Beach, Florida 33021
    United States

    Active - Recruiting

  • Encore Medical Research of Boynton Beach LLC.- Site Number : 8401030

    Boynton Beach, Florida 33021
    United States

    Active - Recruiting

  • Encore Medical Research of Boynton Beach- Site Number : 8401030

    Boynton Beach, Florida 33436
    United States

    Active - Recruiting

  • Doral Medical Research LLC Site Number : 8401094

    Doral, Florida 33166
    United States

    Site Not Available

  • AMR Fort Myers Site Number : 8401111

    Fort Myers, Florida 33192
    United States

    Active - Recruiting

  • Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Doral Medical Research- Site Number : 8401094

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • C&R Research Services - Kendall- Site Number : 8401029

    Kendall, Florida 33183
    United States

    Active - Recruiting

  • Acevedo Clinical Research Associates Site Number : 8401088

    Miami, Florida 33142
    United States

    Active - Recruiting

  • Acevedo Clinical Research Associates- Site Number : 8401088

    Miami, Florida 33142
    United States

    Active - Recruiting

  • C&R Research Services USA, Inc Site Number : 8401029

    Miami, Florida 33183
    United States

    Active - Recruiting

  • C&R Research Services USA, Inc- Site Number : 8401029

    Miami, Florida 33183
    United States

    Active - Recruiting

  • Florida International Research Center Site Number : 8401091

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Florida International Research Center- Site Number : 8401091

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Future Care Solution - Miami- Site Number : 8401144

    Miami, Florida 33142
    United States

    Active - Recruiting

  • Future Care Solutions, LLC Site Number : 8401144

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Sanchez Clinical Research, Inc Site Number : 8401095

    Miami, Florida 33157
    United States

    Active - Recruiting

  • Sanchez Clinical Research- Site Number : 8401095

    Miami, Florida 33157
    United States

    Active - Recruiting

  • Wellness Clinical Research (WCR) Site Number : 8401109

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Wellness Clinical Research - Miami Lakes- Site Number : 8401109

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • K2 Medical Research Site Number : 8401268

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • K2 South Orlando - South Orange Avenue- Site Number : 8401268

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • SEC Clinical Research Site Number : 8401270

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • SEC Clinical Research- Site Number : 8401270

    Pensacola, Florida 32501
    United States

    Active - Recruiting

  • Global Clinical Professionals (GCP)- Site Number : 8401045

    Saint Petersburg, Florida 33705
    United States

    Active - Recruiting

  • Clinical Research Trials of Florida, Inc Site Number : 8401023

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Clinical Research Trials of Florida- Site Number : 8401023

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Paradigm Clinical Research - Boise- Site Number : 8401272

    Boise, Idaho 83709
    United States

    Active - Recruiting

  • Paradigm Research - Boise Site Number : 8401272

    Boise, Idaho 83709
    United States

    Active - Recruiting

  • Paradigm Research - Boise- Site Number : 8401272

    Boise, Idaho 83709
    United States

    Active - Recruiting

  • Skin Sciences, PLLC Site Number : 8401039

    Louisville, Kentucky 40217
    United States

    Active - Recruiting

  • Skin Sciences- Site Number : 8401039

    Louisville, Kentucky 40217
    United States

    Active - Recruiting

  • Velocity Clinical Research at The Dermatology Clinic Site Number : 8401072

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • Velocity Clinical Research at The Dermatology Clinic- Site Number : 8401072

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • BRCR Global Gretna- Site Number : 8401243

    Gretna, Louisiana 70053
    United States

    Active - Recruiting

  • Boesen Research Site Number : 8401269

    Missoula, Montana 59804
    United States

    Active - Recruiting

  • Boeson Research - Missoula- Site Number : 8401269

    Missoula, Montana 59804
    United States

    Active - Recruiting

  • Henderson Clinical Trials Site Number : 8401169

    Henderson, Nevada 89052
    United States

    Active - Recruiting

  • Henderson Clinical Trials- Site Number : 8401169

    Henderson, Nevada 89052
    United States

    Active - Recruiting

  • Pulmonology Group LLC Vikas Sayal Site Number : 8401169

    Henderson, Nevada 89052
    United States

    Active - Recruiting

  • Skin Search Rochester- Site Number : 8401216

    Rochester, New York 14623
    United States

    Active - Recruiting

  • Skin Search of Rochester, Inc Site Number : 8401216

    Rochester, New York 14623
    United States

    Active - Recruiting

  • Velocity Clinical Research - Durham- Site Number : 8401175

    Durham, North Carolina 27701
    United States

    Active - Recruiting

  • Velocity Clinical Research, Durham Site Number : 8401175

    Durham, North Carolina 27701
    United States

    Active - Recruiting

  • Velocity Clinical Research - Springdale- Site Number : 8401153

    Cincinnati, Ohio 45246
    United States

    Active - Recruiting

  • Velocity Clinical Research, Springdale Site Number : 8401153

    Cincinnati, Ohio 45246
    United States

    Active - Recruiting

  • Velocity Clinical Research, Springdale- Site Number : 8401153

    Cincinnati, Ohio 45246
    United States

    Active - Recruiting

  • Velocity Clinical Research - Medford- Site Number : 8401170

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Velocity Clinical Research, Medford Site Number : 8401170

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Best Skin Research, LLC- Site Number : 8401031

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • DermDox Dermatology Centers Site Number : 8401031

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • Vial Health - DermDox Dermatology- Site Number : 8401031

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • Vial Health @DermDox Dermatology Site Number : 8401031

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • DermDox Dermatology Centers Site Number : 8401031

    Sugarloaf, Pennsylvania 18249
    United States

    Site Not Available

  • Velocity Clinical Research - Providence Site Number : 8401179

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • Velocity Clinical Research - Providence- Site Number : 8401179

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • Velocity Clinical Research - Charleston- Site Number : 8401174

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Velocity Clinical Research, Charleston Site Number : 8401174

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Velocity Clinical Research, Charleston- Site Number : 8401174

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Velocity Clinical Research, Columbia Site Number : 8401176

    Columbia, South Carolina 29204
    United States

    Active - Recruiting

  • VitaLink Research - Columbia- Site Number : 8401176

    Columbia, South Carolina 29204
    United States

    Active - Recruiting

  • Velocity Clinical Reseach - Austin Site Number : 8401173

    Austin, Texas 78759
    United States

    Site Not Available

  • Velocity Clinical Research - Austin- Site Number : 8401173

    Cedar Park, Texas 78613
    United States

    Active - Recruiting

  • Modern Research Associates, PLLC Site Number : 8401093

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Modern Research Associates- Site Number : 8401093

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Heights Dermatology & Aesthetic Center- Site Number : 8401143

    Houston, Texas 77008
    United States

    Active - Recruiting

  • Heights Dermatology and Aesthetic Center Site Number : 8401143

    Houston, Texas 77008
    United States

    Active - Recruiting

  • Dermatology Clinical Research Center of San Antonio- Site Number : 8401100

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Dermatology Research Center Of San Antonio Site Number : 8401100

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Discovery Clinical Trials - San Antonio - Stone Oak Parkway Site Number : 8401026

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • Stryde Research - Epiphany Dermatology- Site Number : 8401185

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Stryde Research Epiphany Dermatology- Site Number : 8401185

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Ogden Clinic Mountain View (Avacare) Site Number : 8401167

    Pleasant View, Utah 84404
    United States

    Active - Recruiting

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